CONFERENCE UPDATE: ACC 2026

Clopidogrel outperforms aspirin in reducing thrombotic and bleeding risk in chronic maintenance phase post-PCI with DES: 10-year HOST-EXAM findings

CARDIOLOGY
21 Jul 2026

STUDY DESIGN

Current guidelines recommend indefinite single antiplatelet therapy (SAPT) following 6-12 months of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI).1 Aspirin remains the most widely used standard antiplatelet agent, while clopidogrel is recommended as an alternative strategy.1 Previous trials have suggested that clopidogrel may offer potential benefits in patients with atherosclerotic vascular disease.1 However, no study has definitively established the optimal antiplatelet agent during the chronic maintenance phase after PCI with drug-eluting stents (DES).1

The Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases – Extended Antiplatelet Monotherapy (HOST-EXAM) trial is a prospective, randomized, open-label, multicenter study designed to evaluate the comparative efficacy and safety of aspirin vs. clopidogrel monotherapy in this setting.1 Eligible patients were required to be ≥20 years of age, to have maintained DAPT for at least 12±6 months after PCI with DES, to have no history of clinical events following PCI prior to enrollment, and to provide written informed consent.1 A total of 5,438 patients were successfully randomized 1:1 to receive clopidogrel monotherapy or aspirin monotherapy.1 Baseline characteristics were well-balanced between the treatment groups, including age, demographics, comorbidities, clinical indications, antiplatelet regimen at the time of randomization, and angiographic and procedural characteristics.1

The primary analysis of the HOST-EXAM randomized controlled trial at 2 years after randomization demonstrated that clopidogrel monotherapy was superior to aspirin in reducing clinical events in the intention-to-treat (ITT) population.1 The present analysis extends follow-up to a median of 10.5 years in the ITT population.1

The primary endpoint was patient-oriented composite outcome (POCO), defined as all-cause death, nonfatal myocardial infarction (MI), stroke, readmission due to acute coronary syndrome (ACS), and major bleeding (Bleeding Academic Research Consortium [BARC] ≥3).1 Key secondary endpoints included the thrombotic composite outcome, defined as cardiac death, nonfatal MI, ischemic stroke, readmission due to ACS, and stent thrombosis, as well as any bleeding events (BARC ≥2).1

 

FINDINGS

Primary endpoint:
  • The primary endpoint was POCO, defined as all-cause death, nonfatal MI, stroke, readmission due to ACS, and major bleeding (BARC ≥3)1
  • At a median follow up of 10.5 years, clopidogrel monotherapy reduced the risk of POCO by 14% compared with aspirin (HR=0.86; 95% CI: 0.77-0.96; p=0.0050)1
  • This translated into a number needed to treat (NNT) of approximately 33 to prevent one primary endpoint event over 10 years1
  • Subgroup analyses showed a consistent benefit of clopidogrel over aspirin for POCO in the ITT population1

Secondary endpoints:
  • Key secondary endpoints included the thrombotic composite outcome, defined as cardiac death, nonfatal MI, ischemic stroke, readmission due to ACS, and stent thrombosis, as well as any bleeding events (BARC ≥2)1
  • At a median follow up of 10.5 years, clopidogrel monotherapy was associated with an 18% lower risk of thrombotic composite outcome vs. aspirin (HR=0.82; 95% CI: 0.72-0.93; p=0.0024)1
  • A similar reduction was observed for bleeding outcomes vs. aspirin (HR=0.81; 95% CI: 0.68-0.97; p=0.020)1
  • There was no significant difference in all-cause mortality between groups (HR=1.07; 95% CI: 0·92-1·24; p=0.40)1
  • Treatment effects across subgroups consistently favored clopidogrel vs. aspirin for thrombotic and bleeding outcomes, with heterogeneous findings observed for all-cause mortality1

 

“Clopidogrel may be considered the preferred agent for long-term antiplatelet monotherapy after PCI, given its consistent benefit in reducing both thrombotic composite endpoints and bleeding risk during the chronic maintenance phase.”

Dr. Hyo-Soo Kim
Seoul National University Hospital, South Korea

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